Course Instructor
Lucia Mokres
Consultant to the Biotechnology Industry, Doctor of Veterinary Medicine
Lucia Mokres’s CoursesGXP represents a collection of regulations and guidelines that encompass best practices for various crucial aspects of medical product development. Due to the intricate regulatory environment and the distinctiveness and diversity of medical product innovations, it can be challenging for sponsors to establish a framework for product development and marketing that satisfies regulatory requirements while accommodating the unique needs of the product.
Apart from ensuring compliance and obtaining regulatory product approval, GXP can also serve as a philosophy for fostering a thriving and effective corporate culture throughout the lifespan of a company, from its establishment to its eventual exit.
This 90-minute accredited training session will focus on essential components of GXP and provide insights into its implementation.
Upon completion of this course, you will be able to:
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This course is intended for professionals within all branches of the regulated medical product sector, including Pharmaceuticals, Biologics, Diagnostics and Medical Device industries. Personnel from entry-level to executive performing in the following positions will find the course valuable:
Clinical: Research Associates, Scientists, Study and Site Monitors, Data Specialists, Trial and Operations Managers
Preclinical: Study Scientists, Technicians and Managers
Quality: Engineers, Associates and Managers
Regulatory: Regulatory professionals, whether you are just learning GXP or are senior level and need a refresher, will find this course useful.
Manufacturing: Technicians, Assembly, Engineers, and Supervisors; Shipping/Receiving
Engineering/R&D: Engineers at all levels, Scientists at all levels
Executive Leadership, especially if you are new to medical product development; are in need of a GXP refresher; or are leading an early stage company and want to establish a quality-oriented corporate culture
Lucia Mokres
Consultant to the Biotechnology Industry, Doctor of Veterinary Medicine
Lucia Mokres’s CoursesWhen you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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